Lactulose Solution, USP, 10 g/15 mL, 15 mL unit dose cups (NDC 66689-039-01), packaged in 15 mL x 50 unit dose cups per case (NDC 66689-039-50), Rx only, Manufactured by VistaPharm, Inc., Largo, FL 33771.
Reported: November 30, 2016 Initiated: November 9, 2016 #D-0146-2017
Product Description
Lactulose Solution, USP, 10 g/15 mL, 15 mL unit dose cups (NDC 66689-039-01), packaged in 15 mL x 50 unit dose cups per case (NDC 66689-039-50), Rx only, Manufactured by VistaPharm, Inc., Largo, FL 33771.
Reason for Recall
Microbial Contamination of Non-Sterile Products: bulk solution tested positive for the presence of the bacteria, Burkholderia cepacia.
Details
- Recalling Firm
- VistaPharm, Inc.
- Units Affected
- 1497 cases
- Distribution
- Nationwide
- Location
- Largo, FL
Frequently Asked Questions
What product was recalled? ▼
Lactulose Solution, USP, 10 g/15 mL, 15 mL unit dose cups (NDC 66689-039-01), packaged in 15 mL x 50 unit dose cups per case (NDC 66689-039-50), Rx only, Manufactured by VistaPharm, Inc., Largo, FL 33771.. Recalled by VistaPharm, Inc.. Units affected: 1497 cases.
Why was this product recalled? ▼
Microbial Contamination of Non-Sterile Products: bulk solution tested positive for the presence of the bacteria, Burkholderia cepacia.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 30, 2016. Severity: Moderate. Recall number: D-0146-2017.
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